510(k) · Cleared
Recalled · Class I · 2026Maximus System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hill-Rom Services Pte, Ltd. · NHJ Device, Positive Pressure Breathing, Intermittent
Cleared on May 26, 2020 as substantially equivalent to K192143 (Hill-Rom Services Pte, Ltd., 2020) after a 41-day review. Its family tree reaches back 6 generations to 1995. 2 of the 16 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 10 times, including 9 Class I recalls.
- Decided
- May 26, 2020
- Review
- 41 days
- Class
- Class II
- Product code
- NHJ
- Recalls
- 10 (9 Class I)
- Predicates
- 1
Its longest line of descent runs back 6 generations to K944900 (1995). 12 ancestors in all, the oldest K895485 (1989). 3 later devices descend from it, 2 citing it directly. 2 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK944900 TherapepDhd Diemolding Healthcare Div. · 1995
- 5 generations backK991300 Boeing, Positive Airway Pressure (Pap) Therapy DeviceDhd Healthcare Corp. · 1999
- 4 generations backK051964 PowernebComedica, Inc. · 2005
- 3 generations backK124032 MetanebHill-Rom Services Pte, Ltd. · 2013
- 2 generations backK151689 MetaNeb 4 SystemHill-Rom Services Pte, Ltd. · 2016
- 1 generation backK192143 Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · Recalled (Class I)
- This deviceK200988 Maximus SystemHill-Rom Services Pte, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK231728 BiWaze Clear SystemAbmrc, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK260604 BiWaze Clear SystemAbmrc, LLC · 2026
- Descendant · cites it directly · 0 of its ownK213564 BiWaze Clear SystemAbmrc, LLC · 2022
Class I recalls in this family
- K192143 Maximus Systemdirect predicate · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944900 | Therapep | Dhd Diemolding Healthcare Div. | 1995 | — |
| −5 | K991300 | Boeing, Positive Airway Pressure (Pap) Therapy Device | Dhd Healthcare Corp. | 1999 | — |
| −4 | K051964 | Powerneb | Comedica, Inc. | 2005 | — |
| −3 | K124032 | Metaneb | Hill-Rom Services Pte, Ltd. | 2013 | — |
| −2 | K151689 | MetaNeb 4 System | Hill-Rom Services Pte, Ltd. | 2016 | — |
| −1 | K192143 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020 | Class I |
| 0 (this device) | K200988 | Maximus System | Hill-Rom Services Pte, Ltd. | 2020 | — |
| +1 | K231728 | BiWaze Clear System | Abmrc, LLC | 2024 | — |
| +2 | K260604 | BiWaze Clear System | Abmrc, LLC | 2026 | — |
| +1 | K213564 | BiWaze Clear System | Abmrc, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NHJ device
- #1 K260604 BiWaze Clear Systemscore 14.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K192143 | Maximus SystemSummary page 4…PB) Classification Code/Name: NHJ – non-continuous ventilator (IPPB) 21 CFR 868.5905, Class II Predicate Devices: K192143 – Hill-Rom Maximus™ System Device Description and Modification: The modification is to add the ability to provide aerosol from t… | 2020 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 3, 2026 | Class II | Z-3257-2026 | Device Design | Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications. |
| May 21, 2026 | Class I | Z-2549-2026 | Nonconforming Material/Component | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the… |
| May 21, 2026 | Class I | Z-2551-2026 | Nonconforming Material/Component | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the… |
| May 21, 2026 | Class I | Z-2548-2026 | Nonconforming Material/Component | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the… |
| May 21, 2026 | Class I | Z-2550-2026 | Nonconforming Material/Component | There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the… |
| Feb 18, 2026 | Class I | Z-1637-2026 | Process control | Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue… |
| May 30, 2024 | Class I | Z-2321-2024 | Device Design | Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow. |
| May 30, 2024 | Class I | Z-2322-2024 | Device Design | Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow. |
| Apr 26, 2022 | Class I | Z-1139-2022 | Device Design | There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment. |
| Apr 26, 2022 | Class I | Z-1138-2022 | Device Design | There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment. |
The 5 latest of 10 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K192143Maximus SystemHill-Rom Services Pte, Ltd. · 2020 · Direct predicate · ◆ on the line of descent in FIG. 17 Class I recalls
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 2 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K231728 (Abmrc, LLC, 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NHJ devicesNHJ Device, Positive Pressure Breathing, Intermittent: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NHJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHJ
190in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHJ
11so far in 2026, the most since 2007
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · NHJ
35in 2025
MAUDE reports naming product code NHJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 16 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 3 | 207 | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 3 | 190 | 0 | 3 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 1 | — | 1 (1) | 40 |
| 2025 | 1 | — | 0 | 35 |
| 2026 | 2 | — | 11 (4) | — |
What is it indicated for?
The Maximus™ System provides features of both the Synclara™ System and the Volara™ System. The Maximus™ System, when used as a Synclara™ Cough System is intended for use on patients who are unable to cough or clear secretions effectively due to reduced peak cough expiratory flow or respiratory muscle weakness. The Maximus™ System, when used as a Volara™ System is intended for the mobilization of secretions, lung expansion therapy, the treatment and…
Read the full statement (177 words)
The Maximus™ System provides features of both the Synclara™ System and the Volara™ System.
The Maximus™ System, when used as a Synclara™ Cough System is intended for use on patients who are unable to cough or clear secretions effectively due to reduced peak cough expiratory flow or respiratory muscle weakness.
The Maximus™ System, when used as a Volara™ System is intended for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with oxygen supply.
Patient Population
The Maximus™ System, when used as a Synclara™ Cough System, is intended to deliver therapy to the population of pediatric to adult patients in both acute and home care settings.
The Maximus™ System, when used as a Volara™ System, is intended to deliver therapy to adults and children over the age of 2 in the acute care setting.
The Maximus™ System, when used as a Volara™ System, is intended to deliver therapy to adults and children over the age of 5 in the home care setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200988 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200988: Maximus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200988
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026